Asymmetric mitral annuloplasty band

ABSTRACT

An annuloplasty band and method of implantation. The band is shaped and sized to avoid the adjacent aortic valve structure and better protects against dehiscence along the muscular mitral annulus. The band is asymmetric and when implanted spans more around the side of the mitral annulus having the posterior commissure than the side with the anterior commissure. The band has a saddle shape with a posterior upward bow centered on a minor axis of the mitral annulus, and a span extending clockwise therefrom is longer than a span extending counter-clockwise. The longer span may be about 150° while the shorter span extends about 90°. A set of rings may have different saddle profiles and different plan view shapes for different sized bands. A method includes implanting so that the band extends over the posterior leaflet and a short distance past the posterior commissure outside of the anterior leaflet.

CROSS REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of U.S. Patent Application No.62/173,294, filed Jun. 9, 2015, the entire contents of which areexpressly incorporated herein.

TECHNICAL FIELD

The present disclosure relates generally to annuloplasty bands, andparticularly to a mitral annuloplasty band.

BACKGROUND

In vertebrate animals, the heart is a hollow muscular organ having fourpumping chambers: the left and right atria and the left and rightventricles, each provided with its own one-way valve. The natural heartvalves are identified as the aortic, mitral (or bicuspid), tricuspid andpulmonary, and are each mounted in an annulus comprising dense fibrousrings attached either directly or indirectly to the atrial andventricular muscle fibers. Each annulus defines a flow orifice. The fourvalves ensure that blood does not flow in the wrong direction during thecardiac cycle; that is, to ensure that the blood does not back flowthrough the valve. Blood flows from the venous system and right atriumthrough the tricuspid valve to the right ventricle, then from the rightventricle through the pulmonary valve to the pulmonary artery and thelungs. Oxygenated blood then flows through the mitral valve from theleft atrium to the left ventricle, and finally from the left ventriclethrough the aortic valve to the aorta/arterial system.

The mitral and tricuspid valves are defined by fibrous rings ofcollagen, each called an annulus, which forms a part of the fibrousskeleton of the heart. The annulus provides peripheral attachments forthe two cusps or leaflets of the mitral valve (called the anterior andposterior cusps) and the three cusps or leaflets of the tricuspid valve.The native valve leaflets flex outward when the valve opens and theirfree edges come together or coapt in closure.

The free edges of the mitral leaflets connect to chordae tendineae frommore than one papillary muscle. Mitral valve malfunction can result fromthe chordae tendineae (the chords) becoming stretched, and in some casestearing. Also, a normally structured valve may not function properlybecause of an enlargement of or shape change in the valve annulus. Thiscondition is referred to as a dilation of the annulus and generallyresults from heart muscle failure. In addition, the valve may bedefective at birth or because of an acquired disease. From a number ofetiologies, mitral valve dysfunction can occur when the leaflets do notcoapt at peak contraction pressures. As a result, an undesired back flowof blood from the left ventricle into the left atrium can occur.

Various surgical techniques may be used to repair a diseased or damagedvalve. A commonly used repair technique effective in treatingincompetence is annuloplasty, which often involves reshaping the annulusby attaching a prosthetic annuloplasty repair segment or ring thereto.For instance, the goal of a posterior mitral annulus repair is to bringthe posterior mitral leaflet forward toward to the anterior leaflet tobetter allow coaptation. The annuloplasty ring is designed to supportthe functional changes that occur during the cardiac cycle: maintainingcoaptation and valve integrity to prevent reverse flow while permittinggood hemodynamics during forward flow.

The annuloplasty ring typically comprises an inner substrate or core ofa metal such as a rod or multiple bands of stainless steel or titanium,or a flexible material such as silicone rubber or polyethyleneterephthalate (PET) (e.g., Dacron® PET, Invista, Wichita, Kans.)cordage, covered with a biocompatible fabric or cloth to allow the ringto be sutured to the fibrous annulus tissue. More rigid cores aretypically surrounded by an outer cover of both silicone and fabric as asuture-permeable anchoring margin. Annuloplasty rings may be stiff orflexible, and may have a variety of shapes in plan view, includingcontinuous oval, circular, D-shaped, or kidney-shaped, or discontinuousC-shaped, sometimes referred to as a band. Examples are seen in U.S.Pat. Nos. 5,041,130, 5,104,407, 5,201,880, 5,258,021, 5,607,471 and,6,187,040. Most rigid and semi-rigid annular rings for the mitral valvehave a kidney-like or D shape, with a curved posterior segmentco-extensive with the posterior valve leaflet, and a somewhat straighteranterior segment co-extensive with the anterior valve leaflet.

One popular annuloplasty ring is the partially flexibleCarpentier-Edwards Physio® ring available from Edwards Lifesciences ofIrvine, Calif. The Physio® ring is a “semi-rigid” ring because it offersselective flexibility at the posterior section while preserving theremodeling effect through a rigid anterior section. The newer Physio II®ring from Edwards Lifesciences also features up and down curves tobetter fit the nonplanar contours of the mitral annulus. Various otherrings have posterior bows, e.g., U.S. Pat. Nos. 6,805,710 and 6,858,039,7,959,673, or other three-dimensional configurations.

Despite numerous designs presently available or proposed in the past,there is a need for an annuloplasty ring that better accounts for thenative mitral annulus anatomy.

SUMMARY

The present invention provides an annuloplasty band shaped and sized toavoid the adjacent aortic valve structure and better protects againstdehiscence along the muscular mitral annulus. The band is asymmetric inthat when implanted it spans more around one side of the mitral annulusthan the other. In general, the band extends over the posterior leafletand a short distance past the posterior commissure outside of theanterior leaflet. Looking down on the mitral valve with the anteriorleaflet on top and the posterior leaflet at bottom, a vertical minoraxis can be drawn through the midpoint of both leaflets on which isoriented a minor dimension of the mitral annulus. The annuloplasty bandis discontinuous with a mid-section and two free ends, one on eitherside of the minor axis, and asymmetrically implants farther around themitral annulus toward the posterior commissure than toward the anteriorcommissure so that the circumferential length to the right is greaterthan to the left. Stated another way, the asymmetric position of theimplanted band is rotated in a counter-clockwise (CCW) direction aroundthe mitral annulus from a symmetric position where the center of theband lies on the minor axis. Further, the exemplary annuloplasty bandhas an upward rise or bow in its mid-section that remains centered onthe minor axis such that lengths of the band on either side of the highpoint of the rise are dissimilar. Specifically, a length extendingaround the mitral annulus counter-clockwise (CCW) from the high point ofthe rise is longer than a length extending clockwise (CW). The exemplarydiscontinuous mitral annuloplasty bands disclosed herein have gaps oropenings between their free ends that are configured or adapted to bepositioned against or adjacent the location of the aortic valve aroundthe mitral annulus. This avoids the fibrous structure associated withthe aortic valve, and better protects against dehiscence along themuscular mitral annulus.

The various asymmetrical mitral annuloplasty bands disclosed herein areadapted for implant against a mitral valve annulus. The mitral valveannulus has a posterior aspect to which a posterior leaflet attaches andan anterior aspect to which an anterior leaflet attaches. The annulusgenerally defines a D- or kidney-shape looking at an inflow side thereofwith the anterior aspect being straighter than the more roundedposterior aspect and a minor axis intersecting and extending across theannulus between mid-points on the anterior and posterior aspects beingshorter than a major axis perpendicular thereto intersecting andextending across the annulus, and wherein an anterior commissure and aposterior commissure are located on the annulus at the two junctionsbetween the two leaflets with the anterior commissure located clockwisefrom the mid-point of the posterior leaflet and the posterior commissurelocated counter-clockwise from the mid-point of the posterior leaflet.The annulus also generally defines a saddle shape where the annulusrises up toward the left atrium at mid-points of both the anterioraspect and the posterior aspect. In various embodiments, theannuloplasty bands may be D- or kidney-shaped, oval, planar orthree-dimensional.

A first embodiment of the asymmetrical mitral annuloplasty band has anelongated discontinuous body including an inner generally rigid coresurrounded by a suture-permeable interface, the body defining anasymmetric shape that generally conforms to the shape of the mitralannulus and extends around the entire posterior aspect ending at a firstfree end located approximately at the intersection of the major axis andthe annulus and extending farther around on the opposite side past theintersection of the major axis and the annulus into the anterior aspectand ending at a second free end.

A second embodiment of the asymmetrical mitral annuloplasty band has anelongated discontinuous body including an inner generally rigid coresurrounded by a suture-permeable interface, the body defining anasymmetric shape commencing at a first free end adapted to be implantedadjacent the anterior commissure, a mid-section that extends in acounter-clockwise (CCW) direction around the posterior aspect past theposterior commissure into the anterior aspect and ending at a secondfree end.

And finally a third embodiment of the asymmetrical mitral annuloplastyband has an elongated discontinuous body including an inner generallyrigid core surrounded by a suture-permeable interface, the body definingan asymmetric shape that generally conforms to the shape of the mitralannulus and extends around the entire posterior aspect and includes anupward bow corresponding with the rise in the posterior aspect, whereinthe body extends clockwise along a first span from a mid-point of theupward bow to a first free and extends farther along a second span froma mid-point of the upward bow to a second free end.

In any of the first three band embodiments, a total circumferential spanof the body preferably extends between about 58-67% around the mitralannulus. For example, wherein a first circumferential span of a portionof the body counterclockwise from a mid-point of the posterior aspectextends between about 37-42% around the mitral annulus, and a secondcircumferential span of a portion of the body clockwise from themid-point of the posterior aspect extends between about 21-25% aroundthe mitral annulus. Additionally, the first free end may be adapted tobe implanted at the annulus on the major axis. The first free end ispreferably adapted to be implanted adjacent the anterior commissure andthe ring body extends in a counter-clockwise direction to the secondfree end within the anterior aspect.

In one of the first two band embodiments, the body may also include anupward bow centered at a mid-point of the posterior aspect. Preferably,the body has a partial saddle shape with a first high point at theupward bow, two low points located approximately at the first free endand at a location directly opposite the first free end, and a secondhigh point at the second free end. In addition, the body may have apartial saddle shape with a first high point at the upward bow, two lowpoints located approximately at the first free end and at a locationdirectly opposite the first free end, and a second high point at thesecond free end.

In a fourth embodiment, an asymmetrical mitral annuloplasty bandincludes a top, a bottom, a first end, a second end, and a rigid orsemi-rigid body extending between the first end and the second end, thebody including a first portion and a second portion. The first portionextends counterclockwise along a path from a reference point andterminating at the first end. The second portion extends clockwise alongthe path from the reference point and terminating at the second end. Alength of the first portion is substantially different from a length ofthe second portion, wherein a top view of the path has an oval, D-shape,or a kidney shape with a horizontal major axis and a vertical minor axisdefining a clockface, the reference point is at 6:00, the minor axisintersects the path at 12:00 and 6:00, and the major axis intersects thepath at 3:00 and 9:00 with a flatter portion of the D-shape or kidneyshape above the major axis.

With regard to the fourth band embodiment, the top view of the path ispreferably D-shaped, and the first portion of the body is longer thanthe second portion. The first portion preferably extendscounterclockwise past 3:00, such as the first end being disposed atabout 1:30 or even at about 1:00. In one embodiment, the second portiondoes not extend clockwise to 9:00, and may extend only to about 8:30,although the second portion makes it all the way to 9:00.

A fifth embodiment of an asymmetrical mitral annuloplasty bandcomprising a rigid or semi-rigid open band having a top and a bottom andcomprising a posterior portion and an anterior portion extending from anend of the posterior portion. When viewed in plan view, the open bandextends around a portion of a D- or kidney-shape having a major axis anddefining a longer side having a first perimeter and a shorter sidehaving a second perimeter shorter than the first perimeter. The majoraxis and D- or kidney-shape share a first intersection and a secondintersection, and the D- or kidney shape has a minor axis that shares athird intersection with the longer side and a fourth intersection withthe shorter side. The posterior portion of the open band extends fromthe first intersection along the longer side of the D- or kidney-shape,and the anterior portion of the open band extends from the firstintersection along the shorter side of the D- or kidney-shape.

In the fifth embodiment of asymmetrical mitral annuloplasty band, whenviewed from the top, the longer side is on the bottom and the shorterside is on the top, the first intersection is to the right and thesecond intersection is to the left. The posterior portion preferablydoes not extend to the second intersection of the D- or kidney-shape, orthe posterior portion may extend to about the second intersection of theD- or kidney-shape. The anterior portion desirably does not extend tothe fourth intersection.

In either of the fourth or fifth band embodiments, the asymmetricalannuloplasty band has a saddle shape with peaks at the about theintersections with the minor major axis. Preferably, the saddle shapehas valleys at about the intersections with the major axis. Further, thebody may have a core and a suture permeable cover disposed over thecore. The core may comprise at least one of cobalt-chromium alloy,titanium alloy, stainless steel, or, and may be a solid core, aplurality of bands, or a braided core. The suture permeable coverpreferably includes an elastomeric sleeve disposed around the core and afabric outer cover disposed over the elastomeric sleeve. The suturepermeable cover also may have a radially outwardly projecting sewingflange.

Another aspect of the present application is a set of progressivelysaddled asymmetrical mitral annuloplasty bands comprising a plurality ofsizes of any of the asymmetrical mitral annuloplasty bands describedabove, wherein a ratio of height of the saddle to size of theasymmetrical mitral annuloplasty band is not constant. For example, theratio of height to size increases with size, or the ratio of height tosize varies continuously with size. At a minimum, the ratio of height tosize varies in at least one step with size. Also, a ratio of length ofthe minor axis to size in the set of bands may not be constant. Forinstance, the ratio of length of the minor axis to size increases withsize and may vary continuously with size. At a minimum, the ratio variesin at least one step with size.

Other aspects of the present application are methods of repairing amitral valve in need thereof, the mitral valve comprising an anteriorleaflet including regions A1, A2, and A3; a posterior leaflet includingregions P1, P2, and P3; an antero-medial commissure; a postero-lateralcommissure; and two trigones.

A first method includes securing a mitral band to an annulus of a mitralvalve with a first end thereof proximate to the anterior leaflet, a bodythereof extending around one of the antero-medial commissure or thepostero-lateral commissure; and a second end thereof proximate to theposterior leaflet, or the other of the antero-medial commissure or thepostero-lateral commissure

A second method of repairing a mitral valve in need comprises securing amitral band comprising a first end and a second end to an annulus of amitral valve with the first end proximate to the anterior leaflet andthe second end not proximate to the anterior leaflet.

And finally a third method of repairing a mitral valve includes securinga mitral band comprising a first end and a second end to an annulus of amitral valve with the first end proximate to the anterior leaflet,wherein the mitral band is asymmetric relative to a plane passingthrough A2 and P2.

In the methods described above, securing the mitral band preferablycomprises securing the first end proximate to A3; and the second endproximate to P1 or the antero-medial commissure. Also, securing themitral band desirably comprises securing the mitral band to follow thenatural saddle shape of the annulus of the mitral valve.

A further understanding of the nature and advantages of the inventionwill become apparent by reference to the remaining portions of thespecification and drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

Features and advantages of the present invention will become appreciatedas the same become better understood with reference to thespecification, claims, and appended drawings wherein:

FIG. 1 is a superior or plan view of a healthy mitral valve, with theleaflets closed and coapting at peak contraction pressures duringventricular systole and indicating the primary anatomical landmarks aswell as diagram lines indicating the circumferential reach of bands ofthe present application;

FIG. 2 is a plan view of a mitral valve as in FIG. 1 with an exemplaryannuloplasty band of the present application shown implantedtherearound;

FIGS. 3A-3D are elevational and plan views of an exemplary annuloplastyband of the present invention;

FIGS. 4A and 4B are sectional views of the exemplary annuloplasty bandtaken along corresponding sections lines in FIG. 3B;

FIGS. 5A-5C are elevational and plan views of an exemplary inner corefor the annuloplasty band of FIGS. 3A-3D; and

FIGS. 6A and 6B are sections views of the inner core taken alongcorresponding sections lines in FIG. 5A.

DETAILED DESCRIPTION OF CERTAIN EMBODIMENTS

The present application discloses an asymmetric mitral annuloplasty bandthat avoids the adjacent aortic valve structure and better protectsagainst dehiscence along the muscular mitral annulus. The term “band” isused here since the implant is a discontinuous ring, although in somecontexts such implants are also termed “rings”. Indeed, the bandsdisclosed herein define shapes that circumscribe a majority of themitral annulus, and thus trace most of a ring shape. A complete ringshape may be constructed, and indeed the shape of the bands may bedefined, by imagining an extension of the shape between and connectingthe free ends. For example, the preferred plan view shape of thedisclosed bands is kidney or D-shaped so as to conform to the peripheralshape of the usual mitral annulus. Therefore “band” and “ring” aresynonymous, the disclosed band or ring simply being discontinuous so asto have two free ends.

The term “axis” in reference to the illustrated annuloplasty bands, andother non-circular or non-planar bands, refers to a line generallythrough the centroid of the band or ring periphery when viewed in planview. “Axial” or the direction of the “axis” can also be viewed as beingparallel to the average direction of blood flow within the valve orificeand thus within the band when implanted therein. Stated another way, animplanted mitral band or ring orients about a central flow axis alignedalong an average direction of blood flow through the mitral annulus fromthe left atrium to the left ventricle.

FIG. 1 is a plan view of the mitral valve with posterior being down andanterior being up. In a healthy heart, the annulus of the mitral valveMV creates an anatomic shape and tension such that a posterior leafletPL and an anterior leaflet AL coapt in the flow orifice, forming a tightjunction, at peak contraction or systolic pressures, as seen in FIG. 1.The mitral valve MV annulus has a posterior aspect to which theposterior leaflet PL attaches and an anterior aspect to which theanterior leaflet AL attaches. Where the leaflets meet at the opposingmedial and lateral sides of the annulus are called the leafletcommissures: the anterior (or more accurately, the anterio-medial)commissure AC, and the posterior (or postero-lateral) commissure PC. Theposterior leaflet is divided into three scallops or cusps, sometimesidentified as P1, P2, and P3, starting from the anterior commissure andcontinuing in a counterclockwise direction to the posterior commissure.The posterior scallops P1, P2, and P3 circumscribe particular arcsaround the periphery of the posterior aspect of the annulus, which mayvary depending on a variety of factors, including actual measurement ofthe mitral valve posterior leaflet scallops, and surgeon preference. Asa rule, however, a major axis 22 of the mitral annulus intersects boththe first and third posterior scallops P1 and P3, approximately at thecommissures AC, PC, and a minor axis 24 intersects and generally bisectsthe middle posterior scallop P2. The anterior leaflet also featuresscallops or regions labeled A1, A2, and A3 as indicated in FIG. 1.

The mitral anterior leaflet AL attaches to the fibrous portion FA of themitral annulus, which makes up about one-third of the total mitralannulus circumference. The muscular portion of the mitral annulusconstitutes the remainder of the mitral annulus, and the posteriorleaflet PL attaches thereto. The anterior fibrous annulus FA, the twoends of which are called the fibrous trigones T, forms part of thecentral fibrous body of the heart. The anterior commissure AC and theposterior commissure PC are located just posterior to each fibroustrigone.

The fibrous mitral valve annulus FA is intimate with or adjacent to theaortic valve AV, in particular the left coronary sinus LCS andnon-coronary sinus NCS. The central fibrous body is fairly resistant toelongation, and thus the great majority of mitral annulus dilationoccurs in the posterior two-thirds of the annulus, or around themuscular mitral annulus.

In a preferred embodiment, the mitral annuloplasty bands disclosedherein comprise discontinuous rings defining a kidney or D-shape with asubstantially complete posterior segment centered about a minor axis ofthe band. Further, the annuloplasty band defines two anterior segmentswith free ends opposite each other and having differing lengthsextending from the posterior segment. The different lengths of the twoanterior segments of the band create an asymmetry which is imbalancedtoward the posterior commissure.

To better define the contours of the asymmetric annuloplasty banddisclosed herein, FIG. 1 illustrates a circumferential span 30 aroundthe mitral annulus, generally illustrating the range of lengths of theband. More particularly, the longest length of band extends around in acounter-clockwise (CCW) direction between a radial angular location 32at the anterior commissure AC to a radial angular location 34 that iswithin the fibrous mitral annulus and above the posterior commissure PC.It will be understood that the asymmetric band extends around the mitralannulus in a span that avoids the adjacent aortic valve structures ofthe left coronary sinus LCS and non-coronary sinus NCS. The aortic valveAV is believed to be located slightly offset from the minor axis 24 asshown. In addition, the portion of the right side of the band thatextends around to the posterior commissure PC provides reinforcement andreduces dehiscence, or suture pull-out, in that area. In general, theband extends circumferentially around the posterior leaflet PL and ashort distance past the posterior commissure PC around the anteriorleaflet AL.

To help better define this span, clock positions may be assignedrelative to the major axis 22 and minor axis 24 of the mitral valve MV;that is, the vertical minor axis 24 extends between and defines 12:00and 6:00, and the horizontal major axis 22 extends between and defines3:00 and 9:00. Using this nomenclature, the longest band illustrated inFIG. 1 extends between radial location 32 at about 9:00 and radiallocation 34 at about 1:00. Of course, these geometries may be expressedin percent of a continuous ring or in degrees, and the aforementionedlargest span 30 therefore is about 67% around the mitral annulus orabout 240°.

The radial locations 32, 34 correspond to the free ends of the band.Each free end may be independently shortened as indicated to secondaryradial locations 36 and 38. Radial location 36 is at about 8:30 andradial location 38 is at about 1:30. Consequently, the shortest band mayspan about 58% around the mitral annulus or about 210°. Intermediatebands where one end is shortened but not the other are alsocontemplated, corresponding to bands spanning about 62% around themitral annulus or about 225°.

FIG. 2 illustrates the mitral valve and anatomical landmarks with anexemplary annuloplasty band 40 secured thereto. The band 40 is shapedand sized to avoid the adjacent aortic valve AV structure and betterprotects against dehiscence along the muscular mitral annulus. The band40 is asymmetric when implanted in that it extends farther around oneside of the mitral annulus than around the other. That is, it isasymmetric relative to the minor axis 24 of the annulus. Looking down onthe mitral valve as in FIG. 2, the vertical minor axis 24 extendsthrough the midpoint of both leaflets AL, PL. The annuloplasty band 40is discontinuous with a mid-section 42 and two free ends 44 a, 44 b, oneon either side of the minor axis 24. The band 40 asymmetrically extendsfarther CCW around the mitral annulus toward the posterior commissure PCthan CW toward the anterior commissure AC so that its circumferentiallength to the right is larger or longer than to the left. Stated anotherway, the asymmetric position of the implanted band 40 is rotated in acounter-clockwise (CCW) direction around the mitral annulus from asymmetric position so that the circumferential center of the band(located at about number 46) lies CCW from the minor axis 24.

As seen in FIGS. 3A-3D, the exemplary annuloplasty band 40 has a gentleupward rise or bow 50 along a vertical axis 48 in its mid-section 42that remains centered on the minor axis 24. (The vertical axis 48 isperpendicular to both the major axis 22 and minor axis 24 and extendsthrough their intersection.) The bow 50 diminishes on either side of theminor axis 24 to low points around the ring at about the major axis 22.Since the first free end 44 a lies on or adjacent the major axis 22 italso generally corresponds to a first one of the low points. A secondlow point 52 occurs in the band mid-section 42 along the major axis 22opposite to the first free end 44 a. The band 40 then rises up from thesecond low point 52 toward the second free end 44 b. If the band 40 werecontinuous, as indicated by the dashed line extension 54 in FIG. 3C, itwould define a saddle shape with both the anterior and posteriorsections bowed upward (convex up) with the sides that cross the majoraxis 22 being curved downward (convex down). Of course, this discussionrefers to a relative orientation in which “up” corresponds to the leftatrium and “down” to the left ventricle, so that blood flows downwardthrough the annulus.

As seen in FIGS. 2, 3A, and the bottom view of FIG. 3C, the upward bow50 of the annuloplasty band 40 is centered on the minor axis 24 suchthat lengths of the band on either side of the high point of the bow aredissimilar. Specifically, a first span 60 that extends counter-clockwise(CCW) from the high point of the bow 50 at the minor axis 24 is longerthan a second span 62 that extends clockwise (CW) (directions arereversed in the bottom view of FIG. 3C). As explained above, the spansof the band 40 on either side of the minor axis 24 differ, with thefirst span 60 extending past the posterior commissure PC of the mitralannulus and the second span 62 extending approximately to or just shortof the anterior commissure AC. Using the aforementioned expressions, thefirst span 60 extends CCW from the minor axis 24 to a farthest extent ofabout 1:00 or about 42% (about 150°) around the mitral annulus, whilethe second span 62 extends CW from the minor axis 24 to a farthestextent of about 9:00 or about 25% (about 90°) around the mitral annulus.Further, the first and second spans 60, 62 may independently be somewhatshorter, as indicated by the radial lines 36 and 38 in FIG. 1.

FIGS. 4A and 4B are sections views of the annuloplasty band 40 takenalong corresponding sections lines in FIG. 3B. In a preferredembodiment, the band construction includes a relatively rigid orsemi-rigid inner core 70 surrounded by a suture-permeable interface thatmay include an elastomeric sleeve 72 closely surrounding the core and afabric outer cover 74, for example, a polyethylene terephthalate (PET)fabric cover. In the preferred embodiment the elastomeric sleeve 72,which may be silicone rubber, is molded to have an outwardly-extendingflange 76 to facilitate suturing of the band 40 to the mitral annulus.The band 40 may be secured with sutures, staples, or other such devicesto an inside ledge of the mitral annulus. In a typical procedure, anarray of sutures are anchored through the annulus and then threadedthrough corresponding locations around the band 40, and then the band isparachuted down the suture array to be seated at the annulus beforetying off the sutures.

FIGS. 5A-5C show an exemplary inner core 70 for the annuloplasty band40. The core 70 may comprises a variety of materials and cross-sections,and is shown rectangular in the illustrated embodiment. As indicated bythe sections 4A/6A and 4B/6B taken through different locations of theband 40 and core 70, the core is desirably thicker in a mid-section thantowards free ends 80 a, 80 b thereof. This provides some flexibilitynear the free ends 44 a, 44 b of the band 40 to help avoid dehiscence,or suture pull-out.

The annuloplasty bands of the present invention are “generally rigid” inthat they will resist distortion when subjected to the stress impartedthereon by the mitral valve annulus of an operating human heart. In thissense, “distortion” means substantial permanent deformation from apredetermined or manufactured shape. A number of “generally rigid”materials can be utilized as an inner core of the bands that willperform this function, including various bio-compatible polymers,metals, alloys, and combinations or composites thereof. For example,certain polyesters that resist distortion and also rapid degradationwithin the body may be used (a material that degrades slowly may providethe required initial support). In a preferred embodiment, at least aninner core or body of the annuloplasty band of the present invention ismade of a suitable metal, such as cobalt-chromium (Co—Cr) alloys (forexample, ELGILOY® Co—Cr alloy made by Elgiloy, L.P. of Elgin, Ill.,U.S.A), also titanium or its alloys (for example, titanium-6-4, whichcontains about 6% aluminum and about 4% vanadium by weight), stainlesssteel, nitinol, or combinations thereof.

The core or band body may be one piece, or may include a plurality ofconcentric bands held together or otherwise cooperating elements, or anycombination thereof. Embodiments of one-piece cores include asquare/rectangular cross section, for example, as illustrated in FIGS.6A and 6B, or a core having another shape, for example, a convexpolygon, a circle, or an oval. Other embodiments of the core include atleast one channel, for example, a C-shape or an H-shape cross section.As shown in FIGS. 6A and 6B, the cross-sectional shape can vary alongthe length of the core. As such, some cores include at least one portionthat includes a channel, for example, along the mid-section, and anotherportion without a channel, for example, at one or both ends.

Embodiments in which the core comprises bands include cores in which thebands are stacked radially or concentrically, and/or axially. Theflexibility or rigidity of one or more selected portions of such corescan be adjusted, for example, by varying the number of bands at theportion, changing a thickness of at least one band in the portion,incorporating at least one band comprising a different material, or anycombination thereof. Some embodiments include a spacer between at leastone adjacent pair of bands, for example, a polymer and/or elastomerspacer. Other embodiments of multi-piece cores include braided cores,which are braided from a plurality of wires, strands, and/or braids.

The annuloplasty bands of the present invention are also especiallysuited to correcting particular pathologies. That is, the presentinvention contemplates a set of bands defined by band bodies wherein theproportional shapes of the band bodies change with increasing nominalorifice sizes of the band bodies in the set. The orifice size generallyrefers to the nominal length across the major axis of the band body,although some rings or bands deviate from this nomenclature. Typically,annuloplasty rings and bands have orifice sizes in even millimeterincrements (e.g., 24 mm, 26 mm, etc., up to about 40 mm) as measuredacross the major axes. Other sizing schemes are also possible, forexample, odd millimeter increments, every millimeter increments, orcombination schemes, for example, every millimeter up to a certain size,then even increments above that size. Such rings will have distinctpackaging so as to be labeled with the particular size. The change ofband shape depends on the pathology being corrected. For instance,pathologies resulting in mitral regurgitation may benefit from a set ofbands which have increasing circularity as the band size increases. Itis important to understand that the set of bands is formed of bandbodies that are formed during manufacture to be “generally rigid” andnot easily manipulated. One example is a band core formed of bands ofElgiloy® Co—Cr alloy. It should also be mentioned that holders for suchannuloplasty bands have peripheral shapes that conform to theoptimally-sized bands.

Some sets of the annuloplasty band include progressively sized bands,that is, at least one dimension that does not scale linearly with thelabeled size of the band. Because the labeled size is related to themajor axis length, as described above, the progressivity or nonlinearityis described with respect to the major axis length, unless otherwisespecified. Examples of dimensions that are progressively sized inembodiments of sets include the length of the minor axis, and the heightor degree of saddle. Another variable subject to progressivity isflexibility of at least one portion of the band. Some sets include bandswith combinations of progressive dimensioning, for example, minor axislength and saddle height.

In some sets, every band in the set is progressively sized along atleast one dimension. In some sets, the progressive sizing is applied insteps, for example, to sub-sets or ranges of band sizes rather than onevery individual band. For example, some sets include a first range ofband sizes in which a dimension scales proportionally with size, and asecond range of band sizes in which the same dimension also scalesproportionally with size, but where the proportion is different betweenthe first range and the second range. In some sets, a first range ofsizes is not progressively sized, for example, smaller bands, and asecond range is progressively sized, for example, larger bands.

As discussed above, in some sets, a ratio between the minor axis 24 andmajor axis 22 changes with size. In some embodiments, this aspect ratioincreases with labeled size. For example, some bands described hereincan be defined as a part of a D-shape, as shown in the drawings, butbands for sizes of about 36 mm and up are more rounded. Consequently, insome embodiments, at larger sizes, the band curves become more symmetricin plan view across the major axis 22 (see FIG. 2), at least on thelonger side.

In another example, a set of bands has increasing saddle profiles forlarger sizes, though not linearly increasing. That is, a preferred setof bands has a relatively flat saddle (smaller upward bows) for bandsunder about 30 mm, a constant moderate saddle shape in bands of fromabout 24-30 mm, while the larger bands from about 36-40 mm have morepronounced saddles.

In another set of bands, the saddle increases proportionately with sizeat smaller sizes, and progressively at larger sizes. A variationincludes a middle range in which the saddle increases progressively, butless aggressively than for the larger sizes.

While the foregoing is a complete description of the preferredembodiments of the invention, various alternatives, modifications, andequivalents may be used. Moreover, it will be obvious that certain othermodifications may be practiced within the scope of the appended claims.

What is claimed is:
 1. An asymmetrical mitral annuloplasty band adaptedfor implant against a mitral valve annulus, the mitral valve annulushaving a posterior aspect to which a posterior leaflet attaches and ananterior aspect to which an anterior leaflet attaches, the annulusgenerally defining a D- or kidney-shape looking at an inflow sidethereof with the anterior aspect being straighter than the more roundedposterior aspect and a minor axis intersecting and extending across theannulus between mid-points on the anterior and posterior aspects beingshorter than a major axis perpendicular thereto intersecting andextending across the annulus, and wherein an anterior commissure and aposterior commissure are located on the annulus at the two junctionsbetween the two leaflets with the anterior commissure located clockwisefrom the mid-point of the posterior leaflet and the posterior commissurelocated counter-clockwise from the mid-point of the posterior leaflet,comprising: an elongated discontinuous body including an inner generallyrigid core surrounded by a suture-permeable interface, the body definingan asymmetric shape that generally conforms to a portion of the shape ofthe mitral annulus and extends around the entire posterior aspect endingat a first free end located approximately at the intersection of themajor axis and the annulus and extending farther around on an oppositeside past the intersection of the major axis and the annulus into theanterior aspect and ending at a second free end.
 2. The mitralannuloplasty band of claim 1, wherein a total circumferential span ofthe body extends between about 58-67% around the mitral annulus.
 3. Themitral annuloplasty band of claim 1, wherein a first circumferentialspan of a portion of the body counterclockwise from a mid-point of theposterior aspect extends between about 37-42% around the mitral annulus,and a second circumferential span of a portion of the body clockwisefrom the mid-point of the posterior aspect extends between about 21-25%around the mitral annulus.
 4. The mitral annuloplasty band of claim 1,wherein the body includes an upward bow centered at a mid-point of theposterior aspect.
 5. The mitral annuloplasty band of claim 4, whereinthe body has a partial saddle shape with a first high point at theupward bow, two low points located approximately at the first free endand at a location directly opposite the first free end, and a secondhigh point at the second free end.
 6. The mitral annuloplasty band ofclaim 1, wherein the first free end is adapted to be implanted adjacentthe anterior commissure and the ring body extends in a counter-clockwisedirection to the second free end within the anterior aspect.
 7. Anasymmetrical mitral annuloplasty band adapted for implant against amitral valve annulus, the mitral valve annulus having a posterior aspectto which a posterior leaflet attaches and an anterior aspect to which ananterior leaflet attaches, the annulus generally defining a D- orkidney-shape looking at an inflow side and a saddle shape where theannulus rises up toward the left atrium at mid-points of both theanterior aspect and the posterior aspect, comprising: an elongateddiscontinuous body including an inner generally rigid core surrounded bya suture-permeable interface, the body defining an asymmetric shape thatgenerally conforms to the shape of the mitral annulus and extends aroundthe entire posterior aspect and includes an upward bow correspondingwith the rise in the posterior aspect, wherein the body extendsclockwise along a first span from a mid-point of the upward bow to afirst free and extends farther along a second span from a mid-point ofthe upward bow to a second free end.
 8. The mitral annuloplasty band ofclaim 7, wherein the body has a partial saddle shape with a first highpoint at the upward bow, two low points located approximately at thefirst free end and at a location directly opposite the first free end,and a second high point at the second free end.
 9. The mitralannuloplasty band of claim 7, wherein a total circumferential span ofthe body extends between about 58-67% around the mitral annulus.
 10. Themitral annuloplasty band of claim 7, wherein a first circumferentialspan of a portion of the body counterclockwise from the mid-point of theupward bow extends between about 37-42% around the mitral annulus, and asecond circumferential span of a portion of the body clockwise from themid-point of the upward bow extends between about 21-25% around themitral annulus.
 11. The mitral annuloplasty band of any of claim 7,wherein the first free end is adapted to be implanted at the annulus onthe major axis.
 12. The mitral annuloplasty band of claim 7, wherein thebody has a partial saddle shape with a first high point at the upwardbow, two low points located approximately at the first free end and at alocation directly opposite the first free end, and a second high pointat the second free end.
 13. An asymmetrical mitral annuloplasty bandcomprising: a top, a bottom, a first end, a second end, and a rigid orsemi-rigid body extending between the first end and the second end, thebody including a first portion and a second portion; the first portionextending counterclockwise along a path from a reference point andterminating at the first end; the second portion extending clockwisealong the path from the reference point and terminating at the secondend; and a length of the first portion is substantially different from alength of the second portion, wherein a top view of the path has anoval, D-shape, or a kidney shape with a horizontal major axis and avertical minor axis defining a clockface, wherein the reference point isat 6:00, the minor axis intersects the path at 12:00 and 6:00, and themajor axis intersects the path at 3:00 and 9:00 with a flatter portionof the D-shape or kidney shape above the major axis.
 14. Theasymmetrical mitral annuloplasty band of claim 13 wherein the top viewof the path is D-shaped.
 15. The asymmetrical mitral annuloplasty bandof claim 13, wherein the first portion of the body is longer than thesecond portion.
 16. The asymmetrical mitral annuloplasty band of any ofclaim 13, wherein the first portion extends counterclockwise past 3:00.17. The asymmetrical mitral annuloplasty band of claim 16, wherein thefirst end is disposed at about 1:30.
 18. The asymmetrical mitralannuloplasty band of claim 16, wherein the first end is at about 1:00.19. The asymmetrical mitral annuloplasty band of any of claim 13,wherein the second portion does not extend clockwise to 9:00.
 20. Theasymmetrical mitral annuloplasty band of claim 13, wherein the secondend is at about 8:30.
 21. The asymmetrical mitral annuloplasty band ofclaim 13, wherein the second portion extends clockwise to about 9:00.22. The asymmetrical mitral band of claim 13, wherein the asymmetricalannuloplasty band has a saddle shape with peaks at the about theintersections with the minor major axis.